Search Results

The Ceribell Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in patients greater or equal to 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant", or "Continuous, per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Section notifications will be shown to a user.

The Ceribell Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a training expert.

The Ceribell Seizure Detection Software is a software-only device that is intended to mark previously acquired sections of EEG recordings that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set:
  • Total Number of Patients: 1701
    • Ages 1-11: 450 patients
    • Ages 12-17: 392 patients
    • Ages 18+: 859 patients
• Data Provenance: The EEG recordings dataset used for performance validation was gathered from real-world clinical usage of the Ceribell Pocket EEG Device. The specific country of origin is not explicitly stated, but it's implied to be from acute care hospital settings where the predicate device (Ceribell Pocket EEG Device) is used. The data is retrospective as it was previously acquired. There were no patient inclusion or exclusion criteria applied, indicating a representative sample of the intended patient population.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: More than three expert neurologists (implied by "a two-thirds majority agreement was required"). The tables later specify "3 expert reviewers" for the seizure burden distribution, suggesting at least 3, and possibly more given the "two-thirds majority" rule.
• Qualifications of Experts: Fellowship trained in epilepsy or neurophysiology. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: A two-thirds majority agreement among the expert neurologists was required to establish the ground truth for seizures. This implies a method of consensus. The experts were fully blinded to the outputs of the Seizure Detection Software.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The documentation describes a standalone algorithm performance study, not a comparative effectiveness study involving human readers with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone Algorithm Performance

• Was a standalone study done? Yes. The study directly evaluates the "performance of the Seizure Detection algorithm" by comparing its output (algorithm marks/notifications) against the expert-established ground truth. The algorithm's PPA and FP/hr metrics are presented, which are standard for standalone AI performance.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (specifically, a two-thirds majority agreement among fellowship-trained neurologists reviewing EEG recordings). This is clinical expert ground truth based on visual review of EEG.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The document only mentions that "none of the data in the validation dataset were used for training of the Seizure Detection algorithm; the validation dataset is completely independent." This ensures the integrity of the test set but does not provide information about the training set size.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not explicitly stated. The document focuses exclusively on the validation dataset's ground truth methodology. However, given the nature of deep learning models, it's highly probable that the training data also underwent a rigorous ground truth labeling process, likely similar to (or potentially identical in methodology to) the validation set, though this is not detailed here.

Ask a specific question about this device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording.

The Ceribell Instant EEG Headband is comprised of the following components:

• An elastic fabric headband
• A cable attached to the headband to allow connection to an EEG acquisition/recording device
• 10 electrode assemblies, each consisting of the following:
  • Passive Silver/silver-chloride electrode
  • Reservoir filled with conductive electrolyte gel
  • Mechanism for dispensing gel onto patient scalp
  • Scalp-contacting prongs to prepare scalp for electrode contact

This FDA 510(k) summary for the Ceribell Instant EEG Headband (K232052) explicitly states "Performance Data: None required." and that the device is identical to its predicate (K210805) with only a modified Indications for Use Statement and associated labeling.

Therefore, the provided document does not contain the information necessary to answer the questions regarding acceptance criteria and a study that proves the device meets those criteria. It indicates that no performance data was needed for this specific submission because the device is essentially a re-labeled version of a previously cleared device.

Ask a specific question about this device

The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14.

The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.

The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.

The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device.

The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the 10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The Ceribell Status Epilepticus Monitor underwent clinical validation to assess its performance in diagnosing Electrographic Status Epilepticus (ESE). The primary performance metrics were sensitivity and specificity.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 350 subjects
• Data Provenance: Retrospective study using previously-collected EEG data from 6 hospitals of varying size and geographic locations. The data represents "real-world data" from a fixed one-year time period. All included subjects were ≥ 18 years of age.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A team of "qualified neurologists" (specific number not given, but plural).
• Qualifications of Experts: Described as "qualified neurologists." No further details on years of experience or specific subspecialties are provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: "Majority opinion of the expert reviewers." This indicates a consensus-based approach. For example, if there were three reviewers, at least two would need to agree.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as having been performed. The study focused on the standalone performance of the algorithm against expert-established ground truth.
• Effect Size of Human Readers with vs. Without AI Assistance: Not applicable, as an MRMC study with human-in-the-loop performance was not described.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the study describes the standalone (algorithm-only) performance of the Ceribell Status Epilepticus Monitor. The device algorithm was run on the collected dataset, and its output was compared against the expert-established ground truth.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, a "team of qualified neurologists independently review[ed] and categorize[d] each EEG; the ground-truth reference standard is established by a majority opinion of the expert reviewers."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. The clinical validation study described is a retrospective study of the algorithm's performance on a test set (350 subjects).

9. How the Ground Truth for the Training Set Was Established

• The document does not explicitly state how the ground truth for the training set was established, as details about the training phase itself are not provided in this summary. The focus is on the clinical validation study.

Ask a specific question about this device

The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

The Ceribell Instant EEG Headcap is comprised of the following components:

• An elastic fabric headcap
• An elastic chin strap
• A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes
• A cable attached to the headcap to allow connection to an EEG acquisition/recording device

The Ceribell Instant EEG Headcap is a cutaneous electrode device. The provided text outlines the acceptance criteria and performance data for this device, comparing it to a predicate device (Wuhan Greentek Disposable EEG Electrodes, K200162) to establish substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ceribell Instant EEG Headcap are based on the same requirements as its predicate device and defined by FDA-recognized consensus standards, primarily ANSI/AAMI EC12 Disposable ECG Electrodes and ISO 10993 series for biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test sets (e.g., number of EEG headcaps or subjects) used for each performance test. It only mentions that performance data was "provided" and "completed testing" was done.

Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The Ceribell Instant EEG Headcap is a physical medical device (an electrode headcap), not an AI algorithm or diagnostic tool that requires expert interpretation for ground truth establishment. The performance criteria are objective measurements of electrical properties and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective physical and electrical measurements, not interpretive clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. The Ceribell Instant EEG Headcap is a hardware device for signal acquisition.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical electrode headcap, not an algorithm. Its performance is measured through objective electrical and biocompatibility testing, not algorithmic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the Ceribell Instant EEG Headcap is based on established industry standards and objective measurable physical and electrical properties. For example:

• Electrical Performance: The ground truth is defined by the limits set in ANSI/AAMI EC12.
• Biocompatibility: The ground truth is defined by the pass/fail criteria of ISO 10993 tests (e.g., absence of cytotoxicity, sensitization, irritation).

8. The Sample Size for the Training Set

This is not applicable. The Ceribell Instant EEG Headcap is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Ask a specific question about this device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 2 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording.

The Ceribell Instant EEG Headband is comprised of the following components:

• An elastic fabric headband
• A cable attached to the headband to allow connection to an EEG acquisition/recording device
• 10 electrode assemblies, each consisting of the following:
• Passive Silver/silver-chloride electrode
• Reservoir filled with conductive electrolyte gel
• Mechanism for dispensing gel onto patient scalp
• Scalp-contacting prongs to prepare scalp for electrode contact

The provided document is a 510(k) premarket notification decision letter from the FDA to Ceribell, Inc. regarding their Instant EEG Headband. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the device's diagnostic performance against established acceptance criteria.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The "Performance Data" section within the 510(k) Summary lists the types of testing performed:

• Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10
• Bench testing and simulated use testing to verify system performance including testing and evaluation to ANSI EC12-2000 and IEC 60601-1 requirements.
• Shelf life testing

These tests are related to the safety and functionality of the electrode array itself (biocompatibility, electrical safety, durability, and signal acquisition quality) and not to the diagnostic performance of an AI algorithm or human-in-the-loop performance related to interpreting EEG signals. The device described is a cutaneous electrode array, not an AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria for AI algorithm performance, sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance is not present in this document because the device being cleared is an EEG headband (hardware), not a software algorithm for interpreting EEG.

To answer your request, if this were an AI/software as a medical device (SaMD) submission, the following sections would typically be present, but they are absent here due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance: This would typically define metrics (e.g., sensitivity, specificity, AUC) and their target values, along with the actual results from the study. (Not applicable/Not present)

2. Sample size used for the test set and data provenance:
* Sample Size: Not applicable.
* Data Provenance: Not applicable.

3. Number of experts used to establish ground truth and qualifications:
* Number of Experts/Qualifications: Not applicable, as there is no diagnostic AI component requiring ground truth for interpretation.

4. Adjudication method for the test set:
* Adjudication Method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* MRMC Study: No, this is a hardware device.

6. If a standalone (algorithm only) performance was done:
* Standalone Performance: No, this is a hardware device.

7. The type of ground truth used:
* Ground Truth: Not applicable.

8. The sample size for the training set:
* Training Set Sample Size: Not applicable.

9. How the ground truth for the training set was established:
* Training Set Ground Truth Establishment: Not applicable.

Ask a specific question about this device

The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is "Frequent," "Abundant," or "Continuous," per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.

The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

The Ceribell Pocket EEG Device is a previously cleared EEG monitoring system which includes a portable 8-channel system that is being upgraded in this 510(k) notification K191301 to include a seizure detection module. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels. The device may be used with any scalp EEG electrodes, and the system includes the following components:

• Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system.
• Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device.
• Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
• EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a computer. The EEG Recording Viewer Software includes a Seizure Detection software module that assists qualified users in reviewing and annotating EEG by marking previously acquired sections of EEG that may correspond to electrographic seizures.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 60 subjects (30 from ICU dataset and 30 from EMU dataset).
• Data Provenance: Retrospective. Data was obtained from previous studies that retrospectively reviewed all adult EEGs from patients who underwent inpatient EEG monitoring over a period of time. Data from one hospital was used for ICU EEG data, and data from a second hospital was used for EMU EEG data. The study states the validation dataset was "from previous studies" and "retrospectively obtained from pre-existing EEG databases." The specific country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying the data is likely from the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: An "expert panel" was used, with an agreement between "at least two neurologists required." The exact number of individual experts beyond "at least two" is not specified.
• Qualifications of Experts: EEG trained neurologists (physicians who have obtained fellowship training in epilepsy or neurophysiology). They were affiliated with "multiple different institutions."

4. Adjudication Method for the Test Set

• The ground truth was established by an "expert panel, with agreement between at least two neurologists required to determine the reference standard." This indicates an adjudication method where agreement between at least two experts was necessary. It suggests a form of consensus-based ground truth.

5. Was a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done? If so, what was the effect size of how much human readers improve with AI vs without AI assistance?

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study with human readers assisting the AI or vice-versa was not explicitly described in this document. The study compared the Ceribell device's performance to a predicate device (Persyst 13) and a consensus-based ground truth established by experts. The device's role is to "assist qualified clinical practitioners" but the study format does not evaluate the improvement of human readers with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done?

• Yes, a standalone performance evaluation of the Ceribell Seizure Detection module was done. The module was run on the validation dataset and its performance metrics (PPA and FP/hr) were calculated against the established reference standard. While the device's intended use is to "assist trained medical staff," the validation primarily assessed the algorithm's ability to detect seizures independently.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus. It was established by "EEG trained neurologists who reviewed and annotated the EEG recordings for seizure episodes." Specifically, "Each seizure episode was manually annotated by an expert panel, with agreement between at least two neurologists required to determine the reference standard."

8. The Sample Size for the Training Set

• The sample size for the training set is not specified in the provided document. The document explicitly states that the validation dataset was "completely separate and independent from the data used to design and train the algorithm," and "No patients from the validation dataset were used for algorithm training or development," but it does not provide details on the training data itself.

9. How the Ground Truth for the Training Set Was Established

• The document does not provide details on how the ground truth for the training set was established. It only emphasizes that the validation dataset was separate from the training data.

Ask a specific question about this device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 6 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363) for EEG acquisition and recording.

The Ceribell Instant EEG Headband is comprised of the following components:

• An elastic fabric headband
• A cable attached to the headband to allow connection to an EEG acquisition/recording device
• 10 electrode assemblies, each consisting of the following:
  • Passive Silver/silver-chloride electrode
  • Reservoir filled with conductive electrolyte gel
  • Mechanism for dispensing gel onto patient scalp
  • Scalp-contacting prongs to prepare scalp for electrode contact

The Ceribell Instant EEG Headband is a Class II medical device (product code GXY) intended for single-patient use in recording EEGs for patients aged 6 years and older. It is disposable, non-sterile, and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363). The headband comprises an elastic fabric headband, a cable for connection to an EEG acquisition/recording device, and 10 electrode assemblies. Each electrode assembly contains a passive silver/silver-chloride electrode, a reservoir filled with conductive electrolyte gel, a mechanism for dispensing gel, and scalp-contacting prongs for scalp preparation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each test in the performance data section. It consistently uses the phrase "All samples passed" for each test. The provenance of the data is that it was generated from performance testing conducted on the subject device (Ceribell Instant EEG Headband). The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though performance testing studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the performance data presented primarily consists of engineering and biocompatibility testing against recognized standards (e.g., ANSI/AAMI EC12, ISO 10993) and functional verification tests. These tests do not involve expert interpretation or establishing ground truth in the way clinical studies with human assessors would.

4. Adjudication method for the test set

This section is not applicable for the same reasons above. The performance tests involve objective measurements against predefined criteria in established standards rather than subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not indicate that an MRMC comparative effectiveness study was done. The device described is an EEG electrode array (cutaneous electrode), not an AI-powered diagnostic algorithm or analysis tool. Its purpose is for the recording of EEG signals, not their interpretation or analysis using AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) for signal acquisition, not a standalone algorithm.

7. The type of ground truth used

For the performance tests:

• The "ground truth" or reference for the electrical performance tests (e.g., Impedance, DC Offset Voltage, Bias Current Tolerance, Defibrillation Overload Recovery, Combined Offset Instability and Internal Noise) was the specific requirements and methodologies outlined in the ANSI/AAMI EC12 standard.
• For the biocompatibility tests, the ground truth was the specific requirements and methodologies outlined in ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
• For functional tests (e.g., Conductive Gel Delivery/Skin Prep Testing, Headband Size Range Testing, Simulated Use Testing, Packaging Performance Testing), the ground truth was the pre-defined functional specifications and expected performance criteria established for the device.

8. The sample size for the training set

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This section is not applicable as there is no training set mentioned for this hardware device.

Ask a specific question about this device

The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG monitoring system. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels, and may be used with any scalp EEG electrodes. The Device includes the following items:

• Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. .
• Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
• . Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
• EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.

I am sorry, but based on the provided text, there is no acceptance criteria or study information related to device performance in terms of diagnostic effectiveness or clinical outcomes.

The provided 510(k) summary focuses entirely on:

• Technical specifications and safety testing (e.g., electrical safety, electromagnetic compatibility, battery safety, mechanical robustness).
• Comparison to a predicate device based on intended use and technological characteristics (e.g., number of channels, digital vs. analog technology).

The device is explicitly stated to not provide any diagnostic conclusion or automated alerts. Its function is to "record and to present the EEG signals in visual and audible formats in real time" to "assist trained medical staff to make neurological diagnoses." Therefore, there would not be an "acceptance criteria" related to diagnostic accuracy for this particular device as it does not perform automated diagnosis.

To directly answer your specific questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • No acceptance criteria or reported device performance for diagnostic accuracy or clinical outcomes are mentioned. The performance data listed are for safety and technical standards compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable as no clinical performance study involving a test set for diagnostic accuracy is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no clinical performance study involving ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no clinical performance study involving a test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study or AI assistance is mentioned. The device presents raw EEG signals to trained medical staff.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The device does not provide "diagnostic conclusions" or "automated alerts." It is explicitly a human-in-the-loop device where trained medical staff make diagnoses based on the presented signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable as no clinical performance study requiring ground truth is described.

8. The sample size for the training set:

   • Not applicable as no machine learning algorithm development for diagnostic purposes is described. The device is a data acquisition and presentation tool.

9. How the ground truth for the training set was established:

   • Not applicable as no machine learning algorithm development for diagnostic purposes is described.

In summary, the provided document describes a 510(k) clearance for a medical device that records and presents EEG signals for trained medical staff to interpret, and it focuses on demonstrating the device's technical and safety performance against established standards, not on its diagnostic efficacy or any AI-driven capabilities.

Ask a specific question about this device